MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Catalog Number 319.01

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4).Date of manufacture: nov 25, 2011.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the tip is missing from the depth gauge.It is unknown when the issue occurred, but it was discovered while putting a set together.There was no patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 319.01 with lot number(s) 7625418 is a lot/batch controlled item.The manufacture date of this item is november 30, 2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.A product investigation was completed: the head piece assembly component is missing on the returned device.It is also observed that the needle component is bent on the distal tip but is not broken.This complaint is confirmed.A visual inspection under 5x magnification, functional test, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.This depth gauge is intended for use across various plating procedures.The devices are comprised of four components (slider assembly, guide sleeve, knurled cap, and headpiece assembly) that disassemble for decontamination.However, the device was received without the headpiece assembly component.On the returned device, the knurled cap was confirmed to properly thread on to the respective guide sleeve which would be the function responsible for retaining the headpiece assembly.A review of the current drawing / manufactured revision for the top level assembly, the knurled cap, and the headpiece assembly was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Based on the received condition and the functioning knurled cap, the headpiece assembly components would have been lost while disassembled, such as for cleaning, or while improperly assembled.The bend in the 319.01 needle is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the plastic deformation limit of the material and would not be expected when used as recommended.Overall, the two most likely causes for the damage involve use of excess off-axis force and the method of maintenance.However, given the unknown circumstances at the time of the damage, the root cause could not be definitively determined.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5952141
• MDR Text Key: 54764366
• Report Number: 3003875359-2016-10490
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.01
• Device Lot Number: 7625418
• Other Device ID Number: (01)10886982189950(10)7625418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1